ID
36238
Beschrijving
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis
Trefwoorden
Versies (3)
- 17-04-19 17-04-19 -
- 17-04-19 17-04-19 -
- 23-04-19 23-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 april 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543
Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product
Beschrijving
12 Lead ECG - Dosing Date and Time
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Beschrijving
12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3812758
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
- UMLS CUI [1,3]
- C0040223
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3812758
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C3812758
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG - 30 mins
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG - 1 hr
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG - 24 hr
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs - Pre dose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0439565
Beschrijving
Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiration rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Vital Signs - 30 mins
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Vital Signs - 24 hrs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Pharmacokinetics Blood - GW856553
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0005767
Beschrijving
Dosing date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschrijving
Pre dose - Actual time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0040223
Beschrijving
30 mins - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
1 hr - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
2 hrs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
3 hrs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
4 hrs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
6 hrs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
8 hrs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
10 hrs - Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
12 hrs - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
18 hrs- Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
24 hrs (Day2) - Actual date/time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
36 hrs (Day 2) - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
48 hrs (Day 3) - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
72 hrs (Day4) - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beschrijving
Electronically Transferred Lab Data - Pre dose
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
- UMLS CUI-4
- C0439565
Beschrijving
Haematology Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Haematology sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
Beschrijving
Clinical Chemistry Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Clinical Chemistry sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Urinalysis Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Urinalysis sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Electronically Transferred Lab Data - 24 hrs (Day 2)
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Beschrijving
Haematology Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Haematology sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
Beschrijving
Clinical Chemistry Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Clinical Chemistry sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Urinalysis Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beschrijving
Urinalysis sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beschrijving
Electronically Transferred Lab Data - 72 hrs (Day 4)
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Beschrijving
AST/ ALT Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0200345
- UMLS CUI [3]
- C0201836
Beschrijving
AST/ ALT sampling not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C1272696
- UMLS CUI [2,1]
- C0201899
- UMLS CUI [2,2]
- C0022885
- UMLS CUI [2,3]
- C0870078
- UMLS CUI [2,4]
- C1272696
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Date/ time of dose
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [1,4]
- C0011008
Beschrijving
Did the subject receive the correct treatment during this dosing interval?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Beschrijving
If subject did not receive correct treatment, record reasons
Datatype
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0392360
Similar models
Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product
C0085732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3812758 (UMLS CUI-2)
C0013798 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C3812758 (UMLS CUI-2)
C0013798 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C3812758 (UMLS CUI-2)
C0013798 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0022885 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0201899 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
C1272696 (UMLS CUI [2,4])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])